Below is a cut and paste from the Investor Village website, from the PVCT discussion board. My slight addition as a forward:
PVCT has applied for BreakThroughDrug (BTD) status with the FDA. This simply reduces time to obtain formal approval, slims down the steps needed, and implies that the drug is meeting a need in the market, safety has been proven, and no other drug is performing as well, as safely, and as quickly as PVCT's drug - PV-10 to this point in killing cancer.
There is a timeline for the FDA to respond to Provectus' application for BTD. That timeline is met by the end of this week. The FDA may respond before that, and it may be late (although that is not common for this type of application).
Provectus has recently been uplisted to the NYSE MKT market, leaving the wild west of the OTC:BB behind.
That said, there is a lot of great things happening with the company and the results of PV-10.
With that said, here is the extremely informative thoughts by others from InvestorVillage. All rights are reserved for the appropriate authors.
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newcomers should check Trust Intelligence.com regularly!
comments on this post:
It is a fascinating possibility that trading would/could be halted if a BTD decision happens during market hours.
Would Thursday May 22, sometime after AM bell ringing, make a perfect opportunity for halted traded / btd announcement since pvct staff will all be at CNBC to be interviewed???
who knows I guess---at this rate it could be Monday morning or ________??
My Addition - I would think (hope) it would happen sometime before the bell ringing, thus giving the press and analysts time to formulate questions and such.
Another interesting post below
---compliments of Alan Ross on his Trust Intelligence.com is below!
Selamat Alan!!
pnw1
http://www.trustintelligence.com/forum/viewtopic.php?id=1929&p=8
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Today 13:15:56
agrossfarmFounder
Re: Provectus Biopharmaceuticals (PVCT)
A new Follower on Seeking Alpha wrote to ask me
1. whether I still thought Provectus was undervalued
2. whether they would get accelerated approval
3. and whether the ASCO abstracts would help them get the FDA approval
I thought some of you might have similar questions, so I reproduce my answer, and expanded it a bit, for you here:
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There has been no bad news since I wrote my second Seeking Alpha article in October. The stock is still severely undervalued based upon potential revenue and profits, even if severely discounted for risk. That is why you are seeing more major Pharmas coming onto their advisory board.
I don't know where you heard about Accelerated Approval (AA). Provectus has applied for Breakthrough Therapy Designation (BTD) not AA, which is a related but separate FDA program. BTD will likely be decided by the end of this week. IMO the BTD application will be approved because there is no risk to the FDA given the 100 year safety profile. Plus the drug works better than what is currently available.
PV-10 works better than all the trendy so-called immunological treatments. It also works faster, at lower cost, and with no significant debilitating side effects so even very old, weak and ill patients can be treated.
PV-10 really is a breakthrough drug.
The company is willing to sell for a minimum of $4B plus a contingent value right (that will be worth more than $4 Billion if/when it is approved to treat all solid tumors), which means the upside potential is huge. Risks are typical when dealing with the FDA but refusal of the BTD doesn't put Provectus in a worse situation than they really are in now... which is in the middle of an extended trial on Liver cancer, which is a huge and unbelievably lucrative market. If more research is needed to get an approvable NDA for melanoma, the fact that PV-10 kills cancer cells so fast means the limiting time factor is more how long it takes to enroll enough patients, rather than the length of the treatment regimen or follow-up (given the FDA has approved tumor-response as a primary endpoint).
ASCO ABSTRACTS
The two ASCO abstracts elucidate the drug's effectiveness and the mechanism of immune system boost caused by PV-10 killing cancer cells. The results also illustrate how quickly and reliably PV-10 kills the cancer cells in the treated tumors and how rapidly the PV-10 leads to the enhancement of the patient's immune system so that the untreated tumors are also killed... all even though the patients involved were late stage and had failed standard treatments, meaning they were the most difficult to treat successfully.
This dramatically good data would be available to the FDA Committee deciding on the BTD application. But it is already late in their deliberations so the effect on the decision isn't likely strong, especially given that there already existed data on efficacy and mode of action. We should find out the FDA decision by the end of this Friday if the FDA maintains it good record maintaining it timeline targets... although it is possible that a decision can be made and transmitted at any time to Provectus. I have been told that the decision will be announced by PVCT as soon as practical after the company receives it. If this is during Market hours, trading will be halted pending dissemination of the news. This could take place any time this week.
CONCLUSION
I have continued to add to my position since my first Seeking Alpha article, since I see this as the type of opportunity that doesn't come along many times in an investing career. Your risk-tolerance and investing needs may not be the same as mine so do significant due diligence before risking your money.
I am serious about the need to do Due Diligence on these kinds of investments. Volatility is normal in situations like this and the only logical way to not be scared out prematurely and miss an opportunity of a lifetime is to really understand the company and its product and the likely future, as well as the risks.
I may own, buy, and/or sell the securities mentioned in this post, which is not meant to be investment advice. Everyone should check all material facts with the original source of the information. All original content copyright 2006 through 2014 by Alan Ross |
